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Looking for 3485-62-9 / Clidinium API manufacturers, exporters & distributors?

Clidinium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Clidinium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Clidinium manufacturer or Clidinium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Clidinium manufacturer or Clidinium supplier.

PharmaCompass also assists you with knowing the Clidinium API Price utilized in the formulation of products. Clidinium API Price is not always fixed or binding as the Clidinium Price is obtained through a variety of data sources. The Clidinium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Clidinium

Synonyms

3485-62-9, Quarzan, Clidinium (bromide), Ro 2-3773, Clidinii bromidum, 3-hydroxy-1-methylquinuclidinium bromide benzilate

Cas Number

3485-62-9

Unique Ingredient Identifier (UNII)

91ZQW5JF1Z

Clidinium Manufacturers

A Clidinium manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Clidinium, including repackagers and relabelers. The FDA regulates Clidinium manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Clidinium API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Clidinium manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Clidinium Suppliers

A Clidinium supplier is an individual or a company that provides Clidinium active pharmaceutical ingredient (API) or Clidinium finished formulations upon request. The Clidinium suppliers may include Clidinium API manufacturers, exporters, distributors and traders.

click here to find a list of Clidinium suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Clidinium USDMF

A Clidinium DMF (Drug Master File) is a document detailing the whole manufacturing process of Clidinium active pharmaceutical ingredient (API) in detail. Different forms of Clidinium DMFs exist exist since differing nations have different regulations, such as Clidinium USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Clidinium DMF submitted to regulatory agencies in the US is known as a USDMF. Clidinium USDMF includes data on Clidinium's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Clidinium USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Clidinium suppliers with USDMF on PharmaCompass.

Clidinium WC

A Clidinium written confirmation (Clidinium WC) is an official document issued by a regulatory agency to a Clidinium manufacturer, verifying that the manufacturing facility of a Clidinium active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Clidinium APIs or Clidinium finished pharmaceutical products to another nation, regulatory agencies frequently require a Clidinium WC (written confirmation) as part of the regulatory process.

click here to find a list of Clidinium suppliers with Written Confirmation (WC) on PharmaCompass.

Clidinium NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Clidinium as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Clidinium API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Clidinium as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Clidinium and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Clidinium NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Clidinium suppliers with NDC on PharmaCompass.

Clidinium GMP

Clidinium Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Clidinium GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Clidinium GMP manufacturer or Clidinium GMP API supplier for your needs.

Clidinium CoA

A Clidinium CoA (Certificate of Analysis) is a formal document that attests to Clidinium's compliance with Clidinium specifications and serves as a tool for batch-level quality control.

Clidinium CoA mostly includes findings from lab analyses of a specific batch. For each Clidinium CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Clidinium may be tested according to a variety of international standards, such as European Pharmacopoeia (Clidinium EP), Clidinium JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Clidinium USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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